NOI_75N91023Q00154.pdf

NOTICE OF INTENT (NOI)

NCI NOI No.: 75N91023Q00154

Title: Acquisition of radical OX071 for preclinical Electron Paramagnetic Resonance Imaging

Notice ID Number: 75N91023Q00154 Response Date: 8/10/23 (3:00 pm EST) PSC Code: 6640 - Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

1.0 DESCRIPTION

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA) intends to procure, on a sole source basis, radical OX071 for preclinical Electron Paramagnetic Resonance Imaging from GE Precision Healthcare, LLC., 3000 North Grandview Boulevard, Waukesha, Wisconsin 53188-1615.

The publicizing and response time of the notice for this requirement is in accordance with Federal Acquisition Regulation (FAR) 5.203. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing and the business size standard is 1,000 employees.

2.0 BACKGROUND

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Biology Branch (RBB) requires 10 (ten) grams of OX071, which will be used as an Electron Paramagnetic Resonance (EPR) imaging agent. The RBB conducts pre-clinical studies on an Electron Paramagnetic Resonance (EPR) imaging instrument that is designed, built, and operated by RBB. The EPR imager is used to make spatially resolved measurements of oxygen concentration in the tissues of live animals, using paramagnetic trityl probe OX071 as a contrast agent. OX071 is a deuterated form of OX063, a hydroxyethyl tetrathiatriarylmethyl radical, and can measure a wide dynamic range in vivo. Thus, OX071 is required to further pre-clinical studies within the

CCR.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 REQUIRED ITEMS

The Contractor shall provide the following items:

• ten (10) grams of radical OX071

4.2 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required:

• OX071 shall have a purity of ~90% +/- 5%;

• OX071 shall be clinical/preclinical-grade;

• OX071 shall be supplied in powder form; and

• The product shall be packed and shipped in accordance with the temperature and monitoring requirements in section 4.3

4.3 DELIVERY

The Contractor shall deliver all required items within 60 days of purchase order award. The Contractor shall provide the NCI Technical Point of Contact (TPOC) with tracking information to anticipate delivery to the best extent possible. All shipping/handling (including FOB) and delivery fees shall be included.

The Contractor shall pack the items on dry ice (-80°C) in a sealed Styrofoam package and ship via overnight delivery. The package shall contain a sensor recording device that records the temperature inside of the box from the time of packing at the Contractor’s facility to the time of unpacking at NCI.

The Contractor shall deliver to the following address:

9000 Rockville Pike Bldg. 10, Room B3B35 Bethesda, MD, 20892

Technical Point of Contact (TPOC): TBD AT AWARD

Pursuant to FAR 52.212-4, all supplies to be delivered under this purchase order are subject to final inspection and acceptance by an authorized representative of the Government.

5.0 INVOICE SUBMISSION / PAYMENT

Payment shall be made in full upon delivery, inspection and acceptance by the Government.

Payment authorization requires submission and approval of invoices in accordance with the instructions below. The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-

25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.)

Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the

NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number;

General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov mailto:with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Purchasing Agent (PA) and NCI TPOC :

Purchasing Agent Name: TBD at award Email Address: TBD at award TPOC Name: TBD at award Email Address: TBD at award

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS,

FAR 52.232-40 (NOV 2021)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new https://www.ipp.gov/ mailto:

rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

V. HHSAR 352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (FEB 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

6.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

During the last 30 years, tetrathiatriarylmethyl (TAM) radicals have been widely used as spin probes for oximetry in electron paramagnetic resonance (EPR) spectroscopy and EPR tomography because of the narrow EPR linewidth and high stability in living systems. OX071 is an EPR-active contrast agent that is synthesized exclusively by GE Precision Healthcare. The method of synthesis is proprietary, and no other organization offers this agent or a comparable agent. GE supplied the required items in various quantities in prior years, most recently under NCI purchase order No. 75N91022P00909, in which 20 grams of OX071 was procured. The required items are critical components that work with CCR’s existing equipment. Thus, the agent has been used for all the EPR imaging studies in CCR. It is critically important to procure the same items under identical conditions for the current acquisition, in order for future results to be scientifically comparable to previous experimental results. Therefore, the required items must be procured through the required vendor.

7.0 RESPONSE INSTRUCTIONS

This notice is not a request for competitive quotations. However, if any interested party believes it can meet the requirements, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must http://www.ipp.gov/ contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. All responses must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Thursday, August 10, 2023 (8/10/23). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have valid certification through SAM.gov. Reference: 75N91023Q00154 on all correspondence.